As pharmaceutical companies have expanded target markets and outsourced production over the last decade, the supply chain has become increasingly global, virtual and vulnerable. As a result, counterfeit activity is thriving - and patients have suffered and died from counterfeit and contaminated drugs.
With the Jan. 1 U.S. Drug Supply Chain Security Act (DSCSA) lot-level traceability deadline now behind us, many pharmaceutical companies are turning their attention to full drug serialization. DSCSA requires that manufacturers mark packages with a product identifier, serial number, lot number, and expiration date by 2017. In that period, highly regulated packaging and distribution processes must be changed; physical equipment must be procured and operationalized; enterprise-wide IT must be implemented; and end-to-end serialization testing with supply chain partners must take place well in advance of the deadline to allow time for any necessary adjustments. Given these multi-faceted complexities, three years is an aggressive implementation time frame.